Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710049

FEI Number

3003346138

Entity Name

Phillips-Medisize A/S

City/State/Country

STRUER Midtjylland, DK

Establishment Address

20 GIMSINGLUNDVEJ, STRUER Midtjylland DK-7600, DK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Phillips-Medisize A/S (Owner Number: 9043835)

Owner / Operator Contact Address

Gimsinglundvej 20, STRUER, DK-82 DK-7600, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Skytrofa Auto-Injector 02 FLEXPRO PENMATE BETACONNECT Skytrofa Auto-Injector VYAFUSER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KZH	Introducer, Syringe Needle	General Hospital	Class 2	880.6920	2015-08-19
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2024-10-21

Official Correspondent

No official correspondent registered.

US Agent Details

Mark Sheranko Business: Phillips Medisize Email: MPSUSAgentGIDEU@molex.com Phone: (316) 2268910

Related Public Records

Same Entity

Phillips-Medisize A/S

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K913718	Abbott Laboratories	PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED	1991-10-30
K840616	Advanced Bio Systems, Inc.	MINI-PUMP U-100	1984-03-30
K850183	Deltec Systems, Inc.	CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M	1985-03-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161.
Z-0002-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product codes: 2M8153, and 2M8163.
Z-0005-2025	Zyno Medical LLC	2	Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
Z-0006-2011	CareFusion Corporation	2	CareFusion Alaris PC Unit Model 8015 (formerly Medley PC Unit): Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December 20, 2008 and May 6, 2009; and Alaris PC Units (with logic board part number TC10005572 manufactured and serviced between May 7, 2009 and September 8, 2009. For use with Alaris infusion and monitoring systems.
Z-0007-2012	B Braun Medical, Inc	2	Outlook ES Safety Infusion System, Model 621-100ES, 621-200ES, 621-300ES, and 621-400ES B. Braun Medical Inc., 1601 Wallace Drive, Suite 150, Carrollton, TX 75006 The Outlook ES pump is intended for use with B. Braun Medical Inc., Horizon Pump IV Sets to regulate the flow of primary and secondary fluids when positive pressure is required.

Similar Registrations

Registration Number	Establishment Name	Location
3007115200	Ares Trading SA	Eysins Vaud, CH
1110315	MYLAN PHARMACEUTICALS INC.	Morgantown, WV, US
3005831843	AEROPHARM GmbH	Rudolstadt Thuringia, DE
3004837462	SYNTHON HISPANIA S.L.	Sant Boi de Llobregat Barcelona, ES
3006126537	FLEXTRONICS INTERNATIONAL GMBH	ALTHOFEN Karnten, AT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710049. Last updated year: 2026. Please use registration number 9710049 when referencing this establishment in official correspondence.